Choosing between oral fidaxomicin options

Anna Bischler, Associate Director, Medicines Use and Safety (MUS), Specialist Pharmacy Service Published Last updated See all updates

Local decision makers should choose between the options for giving fidaxomicin orally. Licensing status and other factors affect decision making.

Clostridium difficile

Updated NICE guidance on antimicrobial prescribing in Clostridium difficile infection was published in July 2021

Available options

These options are not presented in any order of preference neither are they exhaustive.

The preferred choice is dependent on the patient and the care setting. Key issues together with their risks and mitigations where appropriate are discussed for each option.

Licensed tablets

Check the patient can swallow tablets.

Risk

If patients are unable to swallow tablets, this can lead to omission or delay, or a choking risk.

Mitigation

Support younger patients to swallow tablets using Medicines for Children advice or consider using this SPS advice on swallowing difficulties or other available preparations.

Crushing licensed tablets

Crushing the tablets makes these methods of administration unlicensed.

Swallowing difficulties

For patients with swallowing difficulties, the tablets can be crushed and mixed with water or apple sauce for administration.

Ongoing advice regarding crushing or mixing tablets depends on the food and fluid the patient is able to swallow safely.

Patients who cannot safely swallow will need to be assessed by a Speech and Language therapist and the swallow assessment report, together with this SPS advice on swallowing difficulties, may be helpful in these situations.

Enteral feeding tubes

In patients with an enteral feeding tube the tablets may be crushed and mixed with water.

Risk

Swallowing difficulties: the patient may not receive the full dose.
Enteral feeding tubes: the tube may become blocked.

Mitigation

Swallowing difficulties

Ensure the patient receives all of the water or apple sauce in which the dose has been mixed. Use of a small portion may assist in supporting the patient to receive the full dose.

Enteral feeding tubes

There is limited data for use via enteral feeding tubes and so this is not recommended unless there are no other options. The tablets are film-coated, so crush well to avoid tube blockage, and flush well after administration to ensure that the entire dose has been given.

Licensed granules for oral suspension

Swallowing difficulties

Granules for oral suspension (40 mg/ml) may be used in patients with difficulties in swallowing tablets depending on the food and fluid the patient is able to swallow safely, as above. Fidaxomicin does not interact with food so administration with food of the appropriate texture would be the preferred option for people who need thickened fluids. Thickening the suspension would not be recommended as it is not possible to assess you have thickened to the appropriate level.

Enteral feeding tubes

Granules for oral suspension are licensed for administration via an enteral feeding tube. Enteral feeding tubes made of polyvinylchloride (PVC) and polyurethane (PUR) have been shown compatible with the oral suspension. Recommended enteral feeding tube size and flush volume of water are available on the Summary of Product Characteristics.

Risk

Delayed and omitted doses may occur if the preparation is not immediately available.

Mitigation

Use an alternative formulation or choice of therapy as clinically appropriate until the product is available.

Oral treatment options for Clostridium difficile

Choosing between oral vancomycin options

Local decision makers should choose between the options for giving vancomycin orally. Licensing status and other factors affect decision making.

Change history

  1. Updated to reflect availability of the granules for oral suspension. Information on administration of the granules via an enteral feeding tube added
  1. Updated to reflect UK stock unavailability of granules until Q2 2022
  1. Updated to include reference to 'safe swallow' and further link to SPS advice.
  1. Published